How to Map Evidence Gaps to Support a Successful Launch
For Medical Affairs, generating clinical data alone is rarely enough to ensure the successful adoption of a therapy. Randomised clinical trials establish safety and efficacy, but they do not always answer the practical questions clinicians face in real-world practice. As a result, even therapies with strong clinical evidence can face uncertainty, slow uptake, or inconsistent use.
For Medical Affairs teams, this challenge increasingly centres on one question:
Where are the evidence gaps that matter most to clinicians and healthcare systems?
Mapping evidence gaps allows Medical Affairs teams to prioritise meaningful evidence generation, align stakeholders, and ensure that the right insights are available when clinicians begin making treatment decisions. A structured approach to evidence gap mapping can also help organisations deploy resources more strategically and avoid producing data that does not meaningfully influence clinical practice.
This article outlines how Medical Affairs teams can systematically identify and prioritise evidence gaps and how consensus approaches can play an important role in addressing areas where traditional clinical research may not provide immediate answers.
Why Evidence Gaps Matter for Therapy Adoption
Clinical development programmes are designed to answer regulatory questions. However, once a therapy enters clinical practice, physicians must answer a broader set of questions, for example:
- Which patients are the most appropriate candidates for treatment?
- How should the therapy fit within existing treatment pathways?
- How should clinicians manage complex or borderline cases?
- What outcomes should be prioritised in different patient populations?
- How should clinicians interpret emerging real-world experience?
Many of these questions cannot be fully addressed during pivotal trials. Trial populations are carefully selected, treatment protocols are tightly controlled, and clinical endpoints are defined according to regulatory requirements rather than everyday decision-making.
As a result, uncertainty frequently emerges when clinicians begin integrating a new therapy into routine care. Without clear guidance, clinicians may rely on local practice patterns, anecdotal experience, or individual interpretation of limited data. This can slow the integration of new therapies into treatment pathways.
Medical Affairs teams are uniquely positioned to anticipate and address these uncertainties through proactive evidence planning.
What Is Evidence Gap Mapping?
Evidence gap mapping is the process of systematically identifying areas where available evidence does not sufficiently answer clinically relevant questions.
Effective evidence gap mapping focuses on the questions that influence clinical behaviour. The goal is to ensure that the evidence available to healthcare professionals supports confident and consistent decision-making throughout the lifecycle of a therapy.
A structured evidence gap analysis typically considers several dimensions:
- Clinical decision points
Key moments where clinicians must make treatment choices.
- Patient populations
Subgroups that may be underrepresented in trials or poorly defined in existing literature.
- Treatment pathways
Where a therapy fits relative to current standards of care.
- Outcomes and endpoints
Which clinical outcomes matter most to clinicians and patients.
- Real-world implementation challenges
Practical considerations that may affect adoption.
By evaluating these dimensions, Medical Affairs teams can develop a clearer view of where uncertainties are most likely to arise as clinicians begin applying the therapy in practice.
Step 1: Starting with the Clinical Decision Journey
A useful starting point for evidence gap mapping is to examine the clinical decision journey for the disease area.
This involves identifying the key stages at which clinicians make decisions, such as:
- Diagnosis and patient identification
- Determining disease severity or risk
- Selecting first-line treatment
- Escalation or switching strategies
- Long-term management and monitoring
Each of these stages presents potential uncertainties. For example, clinicians may lack clarity around which patient characteristics should trigger treatment initiation, or how a new therapy compares with existing alternatives in specific clinical scenarios.
Mapping these decision points allows Medical Affairs teams to anchor evidence planning around real clinical workflows rather than abstract research questions.
Step 2: Reviewing Existing Evidence Systematically
Once the decision journey is defined, the next step is to review available evidence across multiple sources.
These typically include:
- Published clinical trials
- Systematic reviews and meta-analyses
- Observational studies and real-world data
- Clinical guidelines and consensus statements
- Registry data and epidemiological research
The aim is to determine where the evidence base provides clear guidance and where it remains limited or ambiguous.
Common types of evidence gaps include:
- Underrepresented patient populations, such as elderly patients or those with comorbidities
- Unclear treatment sequencing, particularly in rapidly evolving therapeutic areas
- Limited long-term outcome data
- Lack of standardised definitions, for example around disease severity or treatment response
Identifying these gaps enables Medical Affairs teams to prioritise evidence generation activities that address real clinical uncertainty.
Step 3: Engaging External Experts Early
While literature reviews provide important insights, they rarely capture the full complexity of clinical practice. Many evidence gaps become apparent only when experienced clinicians reflect on how they make decisions in real-world settings.
For this reason, early engagement with external experts is a critical component of evidence gap mapping.
Through structured discussions with clinicians, Medical Affairs teams can explore questions such as:
- Which aspects of the disease remain poorly defined?
- Where do clinicians disagree about treatment approaches?
- Which patient scenarios are most difficult to manage?
- What evidence would change clinical behaviour?
These discussions often reveal practical uncertainties that may not be immediately visible in the published literature. For example, clinicians may struggle with identifying appropriate patient populations, interpreting diagnostic criteria, or determining when to escalate therapy.
Understanding these challenges helps Medical Affairs teams focus evidence generation on areas that will have the greatest impact on clinical practice.
Step 4: Prioritising the Most Impactful Evidence Gaps
Not all evidence gaps carry equal importance. Some uncertainties may have little effect on clinical decisions, while others can significantly influence treatment adoption.
Prioritisation therefore becomes a key step in the evidence planning process.
Evidence gaps can be assessed based on several criteria:
- Clinical relevance – Does the gap affect common or high-risk patient scenarios?
- Impact on treatment adoption – Could the gap delay or limit appropriate use of the therapy?
- Feasibility of generating evidence – Can the question realistically be addressed through research or expert consensus?
- Alignment with broader medical strategy – Does addressing the gap support the overall scientific narrative of the therapy?
A focused set of high-priority gaps enables Medical Affairs teams to develop targeted evidence generation plans rather than dispersing resources across too many initiatives.
Step 5: Using Consensus to Address Areas of Uncertainty
Some clinical questions cannot be answered quickly through new clinical trials or observational studies. In these situations, structured expert consensus can provide valuable guidance.
Consensus methodologies such as the Delphi method allow groups of experienced clinicians to evaluate evidence collectively and develop agreement on areas where clinical practice remains uncertain.
These approaches can help clarify issues such as:
- Definitions of patient subgroups
- Appropriate treatment sequencing
- Criteria for initiating or switching therapies
- Interpretation of emerging clinical evidence
Because consensus processes involve multiple experts and structured evaluation of evidence, they provide a transparent and systematic way to address ambiguity in clinical practice.
When conducted rigorously, consensus findings can contribute to scientific publications, educational initiatives, and future guideline development.
Integrating Evidence Gap Mapping into Medical Strategy
Evidence gap mapping should not be treated as a one-off exercise conducted shortly before launch. Instead, it is most effective when integrated into broader medical strategy and evidence planning throughout the product lifecycle.
This means:
- Revisiting evidence gaps as new data emerges
- Aligning evidence generation with lifecycle management
- Coordinating insights across global and regional teams
- Ensuring that medical insights inform future research priorities
By embedding evidence gap analysis within strategic planning, Medical Affairs teams can create a more coherent and proactive evidence generation programme.
Conclusion
The transition from clinical trials to real-world clinical practice is often where the most important questions arise. While regulatory studies establish the fundamental benefits of a therapy, clinicians must still determine how best to apply that therapy in diverse and complex patient populations.
Mapping evidence gaps helps Medical Affairs teams anticipate these challenges and ensure that the evidence supporting a therapy continues to evolve as clinical experience grows.
By analysing clinical decision points, reviewing the existing evidence base, engaging external experts, and prioritising the most impactful uncertainties, Medical Affairs teams can focus their efforts where they matter most.
In doing so, they move beyond simply generating data to building a structured body of evidence that supports confident clinical decision-making and contributes to the successful adoption of new therapies in clinical practice.
How can Triducive help
Triducive is an expert medical communications agency that generates consensus-led evidence, which is published and supports change in healthcare. Through Delphi consensus studies, Triducive has experience in publishing over 50 manuscripts in peer-reviewed journals. Our team of healthcare experts and scientific writers is ready to provide guidance and support at any stage of the evidence generation process. Contact us for more information about Delphi consensus studies.